Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by anECHO, and no clinically significant ECG findings

Baseline oxygen saturation >92% on room air.

Key Exclusion Criteria:

- Known history of infection with HIV or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing